Intended Use

LVivo platform is intended for non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function of patients with suspected disease. In addition, it has the ability to provide Quality Score feedback.

Technology

The LVivo IQS is an AI-based algorithm provided as a software module (API) designed to be integrated into existing ultrasound imaging devices for real-time processing of right ventricle images from 4-chamber apical views, providing automated image quality scoring.

Performance

Performance was validated using retrospective and real-time data from various ultrasound devices and cardiac pathologies, showing 77% agreement with expert sonographer tagging and high clinical interpretability with over 85% medium or better image quality scores.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    3/21/2024

    2 months
  • 2

    FDA Approval

    5/24/2024

Other devices from DiA Imaging Analysis Ltd.

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